FDA Recall D-0272-2025

Central Admixture Pharmacy Services, Inc. · Allentown, PA

Class I — life-threatening Ongoing 448 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.

Lot / code: Lot 37-928390, Exp Date, 03MAR2025; Lot 37-928796, Exp Date, 09MAR2025; Lot 37-928839, Exp Date, 10MAR2025

Quantity: 1546 bags

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-0272-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed nationwide within the United States
Recall initiated: 2025-02-20
Classified by FDA Center: 2025-03-11
FDA published: 2025-03-19
Recalling firm: Central Admixture Pharmacy Services, Inc.
Firm location: Allentown, PA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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